Development of a Medical Device Utilizing an EEG-Based Algorithm for the Objective Quantification of Pain

Chronic Pain Clinical Trial

Official title:

Development of a Medical Device Utilizing an EEG-Based Algorithm for the Objective Quantification of Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03998007
• Other study ID #: 00001
• Status: Completed
• Start date: October 2, 2018
• Est. completion date: January 22, 2019

Study information

• Verified date: June 2019
• Source: PainQx, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Obtained 19 lead EEG data from 50 chronic pain patients along with their clinical history and self-reported pain scored. Machine learning was used to analyze the EEG data and derive a chronic pain biomarker.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 22, 2019
• Est. primary completion date: January 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Male and female chronic pain patients

• Patients between the ages of 18-85 years

• Patients exhibiting the presence of symptoms in excess of 3 months duration

• Patients suffering from neuropathic (e.g., lower back pain), osteoarthritis, or muscular skeletal pain

• Patients with evidence of pathology related to the painful condition on which diagnosis was made (e.g., results of imaging or diagnostic pain code)

• Patients with NRS pain scores across the full range (1-10) at the time of testing

Exclusion Criteria:

• Patients with medically diagnosed psychotic illness

• Patients with medically diagnosed drug or alcohol dependence in the past 12 months

• Patients with a medical history of head injury with loss of consciousness and amnesia (within the last 2 years)

• Patients with skull abnormalities that preclude the proper placement of the electrodes for the EEG data acquisition

• Patients who have a spinal cord stimulator, or other implantable devices

• Patients for whom the source of pain at the time of the evaluation is associated with:

neurological disorders (multiple sclerosis, Parkinson, dementia), diabetes, migraines, or those with reflex / sympathetic dystrophy disorder/complex regional pain syndrome, fibromyalgia, or visceral pain

• Patients with cancer

• Patients on workers compensation or disability

• Patient on anticonvulsant medication

• Patients who have a history of seizures

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Device:
• IRIS System
A QEEG based pain biomarker that scales with the patient reported NRS

Locations

Country	Name	City	State
United States	Boston Pain Care Center	Waltham	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
PainQx, Inc	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pearsons Correlation between IRIS derived pain biomarker and patient reported Numeric Rating Scale (0-10)	A Pearson Correlation of 1.0 is perfection correlation and 0 no correlation between the two measured variables	6 Months